1. Director, NIMH/NIH/DHHS
The National Institute of Mental Health
and the
American Recovery and Reinvestment Act
July 10, 2009
Thomas R. Insel, M.D.
Director, NIMH/NIH/DHHS

2. NIMH Mission
To transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.

3. Burden of Disease (DALYs)
U.S., Canada, and Western Europe years old
Source: WHO World Health Report 2002

4. Public Health Impact: Early Mortality in Individuals with Major Mental Illness (MMI)
Average age at time of death : 56 years
Increased likelihood of heart disease and suicide
Adapted from Colton and Manderscheid, 2006, Prev Chronic Dis

5. Matching Resources with Public Health Need
Direct and indirect components of the economic burden of serious mental disorders, excluding incarceration, homelessness, comorbid conditions and early mortality. ($ in billions)
Health Care Expenditures $ $100.12
Loss of earning $ $193.23
Disability (SSI + SSDI) $ $24.34
Totals $156.0 B $317.6 B
Insel, Am J Psychiatry, 2008

6. Re-Thinking “Mental Illness”
Mental disorders are brain disorders.
Mental disorders are developmental disorders.
Mental disorders result from complex genetic risk plus experiential factors.

7. Mental Disorders are Brain Disorders
Response Pathways for Depression
CBT PF MF
MCC
Cognition
(attention-appraisal-action) hc
Meds PF P
Cg25
PCC BS
MEDS
PF9/46
PM6
Par40
MCC
PCC
mF9/10
na-vst
thal
Mood
state
Self-awareness
insight
pACC24
oF11
amg
mb-vta
Br Med Bul 65: , 2003
Arch Gen Psych 61:
Salience
Motivation
sACC25
a-ins
hth
bstem
Interoception
(drive-autonomic-circadian)

8. Prolonged Human Brain Development
Source: J Giedd, NIMH

9. A Developmental Brain Model for Schizophrenia
Normal Development
Possible Paths to
Schizophrenia
# of
Cortical
Synapses
Psychosis Threshold
Intervention
Age
Based on McGlashan and Hoffman (2000)

10. Complex Genetics of Mental Illness
Penetrance
New technology for sequencing
Repository of DNA from pts/controls
Needed:
Funds for supporting large scale effort
High
Mendelian disease
22q11.2
16p11.1
1q21.1
15q13.3
Disc-1
Intermediate
Rare
Large effect
Modest
ANK3
CACNA1C
HLA
CAM10
Common
Small effect
Low
Frequency of DNA variation in population
Very rare
Rare
Uncommon
Common
McCarthy et al., Nat Rev Genetics 2008

11. NIMH Strategic Plan (4 P’s)
Strategic Objective #1: Pathophysiology
Strategic Objective #2: Predictive medicine
Strategic Objective #3: Preemptive and Personalized Interventions
Strategic Objective #4: Public Health Impact – Participatory Research

12. Nice roadmap but is there any gas in the car?

13. American Recovery and Reinvestment Act (ARRA)- Impact of Economic Stimulus on NIH

14. American Recovery and Reinvestment Act (ARRA)- Objectives
Stimulate the economy
Create and preserve jobs
Advance biomedical research
$10.4B to NIH
$366M to NIMH

15. Scientific Research Approach - NIMH
Stimulate and accelerate biomedical research with existing mechanisms (33%)
Funding additional meritorious R01s, R21s and R03s that have been peer reviewed and approved by NIMH Council
Administrative supplements to accelerate ongoing research
Expand science with new programs (67%)
Revisions to extant programs (“Competitive supplements”)
New ARRA NIH-wide programs
New ARRA IC-specific programs

16. NIMH ARRA Priorities Jumpstart: the NIMH Strategic Plan (4P’s)
the Autism Research Strategic Plan
the NIH AIDS Res Strategic Plan
Increase training, faculty recruitment, diversity
Support beaker-ready projects w 2 year outcomes
Process: transparent, careful, accountable

17. New ARRA NIH-wide Programs
Challenge Grants
Grand Opportunities (“GO” Grants)
Recruit new faculty to conduct research
Provide summer jobs for high school /
college students and teachers in science labs
AREA (R15) Grants }
Jumpstart
Strategic Plans }
Create and
Retain Jobs }
National effort
On average, every NIH grant supports 6 -7 part-time or full-time jobs

18. Challenge Grants NIMH Challenge Areas: Biomarkers Genomic sequencing
2 year $500k/yr awards – submitted April 27, 2009
Received >21,000 proposals, 894 for NIMH
Reviewed June-July, Funded before 9/30/09
NIH OD committed $200M; NIMH has committed $90M
NIMH Challenge Areas:
Biomarkers
Genomic sequencing
Schizophrenia interactome
AIDS – behavior change
Comparative Effectiveness
Developing iPS cells

19. Grand Opportunity Grants
2 year >$500K/yr awards – submitted May 24, 2009
Received 104 proposals for NIMH ($470M)
Reviewed June; Funded before 9/30/09
NIMH has committed $67M
NIMH GO Grants:
Genomic profiling of mental disorders
Neurodevelopmental genomics
Transcriptional map of developing human brain
Clipart images

20. ARRA NIMH RFA: Research to Address the Heterogeneity of Autism Spectrum Disorders
4 Different mechanisms to address heterogeneity of autism and focus on short-term objectives of IACC Strategic Plan
590 proposals ($500M) submitted May 12; Peer reviewed June 19; Scheduled for Council July 17
Combined commitment is $60M (NIMH, NICHD, NINDS, NIDCR, NIEHS)

21. Peer Review for ARRA Rapid (initial mail reviews within 1 month)
Extensive (364 reviewers for NIMH GO and autism proposals)
Careful (Two tier review to ensure quality)
Public input (Autism review included consumers)

22. Transparency:

23. Accountability:

25. NIMH Signature Project #1
Reducing Suicide in the Army
Problem: Suicide rates in Army have doubled
Army asked for assistance in assessing risk and resilience in soldiers
NIMH commits ARRA funds ($10M) to collaborative effort for historic epidemiological study to follow 15,000 soldiers
Study to provide actionable information to Army

26. NIMH Signature Project #2
Recovery After an Initial Schizophrenic Episode (RAISE)
Problem: Schizophrenia associated with chronic disability
RAISE will test aggressive, comprehensive treatment
(medication, psychosocial, rehabilitation) to optimize outcomes
RAISE developed with SSA, SAMHSA, and CMS for “hand off” from research to practice
NIMH ARRA funds ($25M) will launch project in 2009

27. NIMH Signature Project #3
Neurogenomics
Problem: Many leads but few genes for psychiatric illnesses (rare variants likely but difficult to detect)
New techniques permit rapid, comprehensive sequencing, including detection of rare variants
Sequencing is feasible in 2 years
NIMH ARRA funds ($20 -30M) will support development of first comprehensive sequencing efforts

28. NIMH Signature Project #4
Developmental Human Brain Atlas
Problem: Absence of a reference atlas for human brain development
New techniques permit mapping regional gene expression in the developing human brain
Mapping is labor intensive but feasible in 2 years
NIMH ARRA funds ($20M) will support development of the digital public resource

29. NIMH Comparative Effectiveness Research
ARRA Projects:
Leveraging existing healthcare networks for CER on Mental Disorders and Autism
Cost effectiveness of mental health interventions
Collaboration with AHRQ CER Program
Building ASD registries for use in Comparative Effectiveness Research

30. What Can We Accomplish With ARRA?
Biomedical Progress:
Creating a foundation for future progress
Creating and Preserving Jobs:
>50% of grant budget = personnel
Economic Stimulus:
Proposals from all 50 states

31. NIMH ARRA obligations actual and planned for FY2009
(all mechanisms)

32. Summary
ARRA provides an unprecedented opportunity to advance biomedical research while participating in the nation’s economic recovery
NIMH is using ARRA funds to jumpstart its strategic plan, support autism and AIDS research, and provide training and faculty positions.
Specific signature projects focus on suicide in the Army, schizophrenia, and genomics.
Demand for ARRA support high, success relatively low, but ARRA will build foundation for progress.

33. Paving the Way for Prevention, Recovery, and Cure 33

34. Select NIMH ARRA Funds – 7/10/09
Initiative
Committed funding
Due Date
Proposals
received
Funding Date
Expansion of payline
$60M
-----
6/09
Supplements
$10M adm.
$10M comp.
4/09
$205M
$ 64M
8/09
Challenge
$90M
$578M
Grand Opportunity
$67M
5/09
$470M
9/09
New faculty
recruitment
$5M
$25M
Autism RFA
$30M
$500M
7/09
Army suicide
& RAISE
$35M
2009

35. What Happens After ARRA?
Demand for research will increase:
Success rate (# funded/# proposed) < 10%
Many unsuccessful grants return in 2010
Both unsuccessful and successful grants return in 2011
Total # ARRA proposals = 1,703
Estimated success rate in 2011:
If 50% return: 13.7%
If 75% return: 12.2%
If 90% return: 11.5%
Required for 20% success rate: 7 -11% increase from FY10 PB